(84 days)
Not Found
No
The description focuses on a semiconductor oxide sensor and resistance measurement based on Henry's law, with no mention of AI or ML technologies.
No.
The device is used for diagnosis (measuring alcohol in breath for diagnosis of intoxication), not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of alcohol intoxication." This indicates its role in identifying or confirming a medical condition, which is a characteristic of a diagnostic device.
No
The device description explicitly details hardware components like a semiconductor oxide sensor, alumina substrate, gold electrodes, and a ruthenium oxide heater, indicating it is a physical device, not software-only.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements obtained by this device are used in the diagnosis of alcohol intoxication. This is a key characteristic of an IVD, as it's used to provide information for diagnostic purposes.
- Sample Type: The device measures alcohol in human breath. While breath is not a traditional "in vitro" sample like blood or urine, the FDA's definition of IVD includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body. Breath is a specimen taken from the human body.
- Mechanism: The device uses a sensor to analyze the chemical composition of the breath sample to determine the presence and concentration of alcohol. This analysis of a biological specimen is consistent with the function of an IVD.
While the device is used over-the-counter and measures breath, the diagnostic intent and the analysis of a human specimen firmly place it within the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
The Alcohawk Precision™ is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The Alcohawk Precision™ is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench, DOT, and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/-0.01%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
1(09)3188
EXHIBIT 2
510(k) Summary Q3 INNOVATIONS, LLC 1520 Oakbrooke Lane Eagan, MN 55122 Telephone: 651-762-5728 Fax: 651-905-3954
November 2, 2004
Contact: Brian Eddy, CEO/CFO
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Identification of the Device: 1.
Proprietary-Trade Name: Alcohawk Precision™ Digital Alcohol Detector Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system -
Equivalent legally marketed devices AlcoMate CA2000™ Digital Alcohol Detector 2. manufactured by Han International, K041334
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Indications for Use (intended use) : The device is intended to measure alcohol in the human 3. breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
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Description of the Device: The Alcohawk Precision™ is designed to measure deep lung air to 4. test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The Alcohawk Precision™ is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
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- Safety and Effectiveness, comparison to predicate device. The results of bench, DOT, and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device.
1
| Feature | AlcoMate CA2000 K041334 | Alcohawk Precision™ |
|---|---|---|
| INDICATION For USE | The device is intended to measure | |
| alcohol in the human breath. | ||
| Measurements obtained by this | ||
| device are used in the diagnosis of | ||
| alcohol intoxication. | SAME | |
| MODE | Breath Alcohol Concentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| DISPLAY | 3 Digit LED | 4 Digit LED |
| POWER SOURCE | 9 Volt Alkaline Battery | SAME |
| BATTERY LIFE | 300 Tests | 100-300 tests |
| Measurement Range | .00-.40% | SAME |
| Accuracy | +/-0.01% | SAME (+/- .009%) |
| TYPE OF SENSOR | Semiconductor-Oxide Sensor | SAME |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable | SAME |
| Warm Up Time | 20 Seconds | 15-60 Seconds |
| Blowing Time | 5 Seconds | SAME |
| DOT Approval | YES | YES |
| Construction | Plastic case with internal circuit | |
| board | SAME | |
| SIZE | 5" x 3 ½" | 4.25" x 2.75" |
| WEIGHT | 200 grams | 130 grams |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data, it is the conclusion of Q3 INNOVATIONS, LLC that the Alcohawk Precision™ is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. The clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device, and obtain results that were comparable to those provided by a professional unit administered by a trained observer.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with a bird-like figure in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus.
FEB - 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
03 Innovations, LLC c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, IL 60015
K043188 Re:
Trade/Device Name: AlcoHawk™ Precision Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: November 5, 2004 Received: November 26, 2004
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ____AlcoHawk™ Precision
Intended to measure alcohol in the human breath. Indications For Use: Maloutions For Society - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benam
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
510(k) K043188